The role
04The Technical Lead is pivotal in ensuring technical excellence, regulatory compliance, and the continuous improvement of manufacturing processes. The incumbent will drive cross-functional collaboration to support the launch and lifecycle management of products, technology transfers, and the implementation of innovative methodologies.
01Subject matter expert (SME) for DS Biologics manufacturing.
02Process owner of DS Biologics validation for Sobi products.
03Lead and execute MSAT projects such as manufacturing process and cost improvement as part of life-cycle management (LCM).
04Participate in and lead internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs.
05Issue, review and approve applicable internal and external SOP’s and manufacturing instructions.
06Review and supervise set up, execution and documentation of technical studies, qualifications and validations.
07Write and review applicable sections of the APR/PQR.
08Write and review applicable sections in registration files, variations and market expansion, as well as answer Health authorities requests and questions.
09Support in sourcing evaluation of new DS Biologics contract manufacturers and participation in developing supply and quality agreements.
10Lead the process components of the product transfer, scale up activities, validations and oversee manufacturing of DS Biologics processes at external manufacturers for Sobi projects in clinical and commercial phase.
11Be aware of external pharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.
12Represent SAT in product governance teams as needed, including potentially coordinating the oversight and escalation of DS, DP and Analytical project portfolio.
13Support SAT and Sobi’s continuous improvement program for internal business processes, systems and templates.
